DOSAGE AND ADMINISTRATION
For intramuscular use only. The dosage regimen employed
in any particular case will depend upon the indication for the use, the age and
weight of the patient, and the physician's preference. The following regimens
have been advocated by various authorities:
Prepubertal Cryptorchidism Not Due To Anatomical Obstruction. Therapy Is Usually Instituted In Children Between The Ages Of 4 And 9
4000 USP units 3 times weekly for 3 weeks.
5000 USP units every second day for 4 injections.
15 injections for 500 to 1000 USP units over a period of
500 USP units 3 times weekly for 4 to 6 weeks. If this
course of treatment is not successful, another series is begun 1 month later,
giving 1000 USP units per injection.
Selected Cases Of Hypogonadotropic Hypogonadism In Males
500 to 1000 USP units 3 times a week for 3 weeks,
followed by the same dose twice a week for 3 weeks.
4000 USP units 3 times weekly for 6 to 9 months,
following which the dosage may be reduced to 2000 USP units 3 times weekly for
an additional 3 months.
Induction of ovulation and pregnancy in the
anovulatory, infertile woman in whom the cause of anovulation is secondary and
not due to primary ovarian failure and who has been appropriately pretreated
with human menotropins. (See prescribing information for menotropins for
dosage and administration for that drug product.)
5000 to 10,000 USP units 1 day following the last dose of
menotropins. (A dosage of 10,000 USP units is recommended in the labeling for
Directions for Reconstitution
Two-vial package: Withdraw sterile air from lyophilized
vial and inject into diluent vial. Remove 1–10 mL from diluent and add to
lyophilized vial; agitate gently until powder is completely dissolved in solution.
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution
and container permit.
IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION.
RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.
Two-vial package containing:
1-10 mL lyophilized multiple dose vial containing: 10,000
USP units chorionic gonadotropin per vial, NDC 0052-0315-10.
1-10 mL vial of solvent containing: water for injection
with sodium chloride 0.56% and benzyl alcohol 0.9%, NDC 0052-0325-10.
|When reconstituted, each 10 mL vial contains:
||10,000 USP units
|Monobasic sodium phosphate
|Dibasic sodium phosphate
If required pH adjusted with sodium hydroxide and/or
Store at controlled room temperature 15-30°C (59-86°F).
Reconstituted solution is stable for 60 days when refrigerated.
PREGNYL® manufactured by: Baxter Oncology GmbH, Halle 33790,
Germany. PREGNYL Solvent manufactured by: Baxter Pharmaceutical Solutions LLC, Bloomington,
IN 47403, USA. Merck Sharp & Dohme B.V., a subsidiary of Merck & Co.,
Inc. Manufactured for: Merck Sharp
& Dohme Corp., a subsidiary of MERCK & CO., INC.,Â Whitehouse Station,
NJ 08889, USA. Revised: Jan 2015